Brand Name | R3 ACETABULAR LINER WITH NO HOOD |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
1450 brooks road |
memphis TN 38116 |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
1450 brooks road |
|
memphis TN 38116 |
|
Manufacturer Contact |
markus
poettker
|
schachenallee 29 |
aarau 05001
|
SZ
05001
|
|
MDR Report Key | 7154223 |
MDR Text Key | 96033160 |
Report Number | 1020279-2017-01358 |
Device Sequence Number | 1 |
Product Code |
MBL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
02/28/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
10/06/2017 |
Initial Date FDA Received | 12/29/2017 |
Supplement Dates Manufacturer Received | 10/06/2017
|
Supplement Dates FDA Received | 02/28/2018
|
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | OXINIUM FEMORAL HEAD 36 MM+0, PART&LOT# UNKNOWN |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 56 YR |
|
|